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Omaveloxolone for Friedreich's Ataxia
Study Summary
This trial is testing a drug called omaveloxolone (RTA 408) to see if it is safe and effective in treating Friedreich's ataxia, a cerebellar ataxia caused by an expansion of a certain trinucleotide repeat. The study will be conducted in two parts, with the first part testing different doses of the drug to see what the safe range is, and the second part testing the efficacy of the 150 mg dose. The trial will also have an extension to assess the long-term safety and tolerability of the drug.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- My condition is genetically confirmed Friedreich's ataxia.Your modified FARS score is between 20 and 80.I am between 16 and 40 years old.I have not taken and will not take certain drugs that affect liver enzymes or drug transporters during the study.My diabetes is not under control (HbA1c >11.0%).I have difficulty understanding or remembering things, which may affect my ability to follow study procedures.You can complete a very challenging exercise test.I do not have any active infections, including HIV or hepatitis.My FARS score is between 20 and 80.I can swallow pills.You have important problems with your blood or body chemistry, like high levels of certain enzymes.Your B-type natriuretic peptide level is higher than 200 pg/mL.I have previously participated in a trial with omaveloxolone.Your modified FARS score is between 20 and 80.You are able to do the most intense exercise tests.You are currently using drugs or drinking alcohol excessively.I can swallow pills.I have a history of serious heart disease.I can swallow pills.
- Group 1: Part 1 Omaveloxolone Capsules 10 mg
- Group 2: Part 1 Omaveloxolone Capsules 2.5 and 5 mg
- Group 3: Part 1 Omaveloxolone Capsules 20 mg
- Group 4: Part 1 Omaveloxolone Capsules 40 mg
- Group 5: Part 1 Omaveloxolone Capsules 80 mg
- Group 6: Part 1 Omaveloxolone Capsules 160 mg
- Group 7: Part 1 Omaveloxolone Capsules 300 mg
- Group 8: Part 1 Placebo Capsules
- Group 9: Part 2 Placebo Capsules
- Group 10: Part 2 Omaveloxolone Capsules 150 mg
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there still vacancies available for participants in this clinical trial?
"This medical study is no longer recruiting participants, with the latest edits being applied on November 4th 2022. As an alternative, there are currently 46 clinical trials involving Friedreich ataxia and one trial for Omaveloxolone Capsules (150 mg) that have open enrollment positions available."
How many enrollees will this research endeavor feature?
"Unfortunately, no additional participants are being accepted into this clinical trial. The post was made on the first of January 2015 and last modified on the fourth of November 2022. Fortunately, 46 trials for those with Friedreich ataxia and one study for Omaveloxolone Capsules (150 mg) remain open to volunteers."
What have been the observed effects of ingesting Omaveloxolone Capsules, 150 mg?
"The safety of Omaveloxolone Capsules, 150 mg was evaluated at a 2 due to the lack of clinical evidence that confirms its efficacy. However, there is some data available confirming this drug's safety."
Are there any other investigations regarding the efficacy of Omaveloxolone Capsules, 150 mg?
"Omaveloxolone Capsules, 150 mg was initially trialled at Children's Hospital of Philadelphia in 2015. Since then, 18335 clinical trials have concluded with 1 presently being actively recruited from various clinics located in Tampa, Florida."
Is this undertaking a pioneering venture?
"AbbVie's Omaveloxolone Capsules, 150 mg is now being tested in just one live research study spanning 5 countries and 8 cities. This pharmaceutical drug was trialled for the first time in 2015 with 172 patients - eventually reaching Phase 2 approval. Since then, 18335 additional trials have been conducted."
Does my profile qualify me to partake in this clinical research?
"This clinical trial is in search of 172 people with friedreich ataxia, ranging from 16 to 40 years old. Essential criteria for consideration include a modified FARS score between 20 and 80 inclusive, male or female gender identity, capacity to swallow pills, ability to perform maximal exercise tests and no significant alteration to the current physical routine within 30 days before commencement."
Does this investigation include elderly participants?
"This trial seeks volunteers aged 16 to 40; while there are 18 clinical trials for those under the legal age of consent, 33 studies exist that focus on elderly individuals."
How many geographical locations has this clinical experiment been conducted in?
"The USF Ataxia Research Center in Tampa, Florida, Ohio State University - Neurology in Columbus and the University of Iowa Stead Family Children's Hospital in Iowa City are just some of the locations offering this clinical trial. There are an additional 7 research centres administering it as well."
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What portion of applicants met pre-screening criteria?
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